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临床试验/NCT03485625
NCT03485625已完成3 期

Adjuncts to Intravenous Regional Anaesthesia, a Comparison Between Ketorolac and Paracetamol

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年3月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
60
试验地点
1
主要终点
The time to first analgesic request.

研究概览

简要总结

The study was planned to compare the effect of ketorolac 20 mg to 300 mg of paracetamol when added to lidocaine 3 mg/kg for Intravenous regional anaesthesia.

详细描述

All patients were premedicated 15 minutes before the surgical procedure with I.V. 0.06mg/kg of midazolam. In the operating room, patients were monitored for non invasive blood pressure (NIBP), oxygen saturation (Spo2) and pulse rate (PR).

Two cannulae were placed, one in a vein on the dorsum of the operative hand and the other on the non operative hand for i.v fluids. The operative arm was elevated for 2 min and was then exsanguinated with an elastic bandage. A pneumatic tourniquet was then placed around the upper arm, and the cuff was inflated to 100 mm Hg above systolic BP. Circulatory isolation of the arm was verified by inspection, absence of a radial pulse, and a loss of the pulse oximetry tracing in the ipsilateral index fingers. The solutions were prepared by an anesthesiology assistant not involved in any part of the study. The solutions were injected over 90 s by an anaesthesiologist. During surgery if patient reported pain during operation (VAS 4 or greater) inj. fentanyl 1 μg/kg was given and total amount used was recorded. Postoperatively patients were questioned for pain and if VAS > 4, 75 mg intramuscular diclofenac was given.Total amount used was recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
17 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anaesthesiologists (ASA) physical status I or II, who will be scheduled for surgery of the hand or the forearm were included in this study after informed consent

排除标准

  • Severe Raynaud's Disease
  • Sickle Cell Disease
  • Crush injury to the limb
  • A history of allergic reaction to lidocaine
  • Liver disease or kidney disease
  • Significant cardiovascular disease
  • Highly nervous and uncooperative patients
  • Patient with history of opioid dependence
  • Drug or alcohol abuse
  • Psychiatric disorder
  • Neurological diseases

研究组 & 干预措施

Lidocaine

Experimental

Patients in group C will receive 3 mg/kg of lidocaine 2% diluted with saline to a total volume of 40 ml.

干预措施: Lidocaine (Drug)

Lidocaine+ Ketorolac

Experimental

Patients in group K receive 3 mg/kg of lidocaine 2% + 20 mg ketorolac diluted with saline to a total volume of 40 ml.

干预措施: Lidocaine (Drug)

Lidocaine+Paracetamol

Experimental

Patients in group P will receive 3 mg/kg of lidocaine 2% + 300 mg paracetamol diluted with saline to a total volume of 40 ml.

干预措施: paracetamol (Drug)

Lidocaine+ Ketorolac

Experimental

Patients in group K receive 3 mg/kg of lidocaine 2% + 20 mg ketorolac diluted with saline to a total volume of 40 ml.

干预措施: Ketorolac (Drug)

Lidocaine+Paracetamol

Experimental

Patients in group P will receive 3 mg/kg of lidocaine 2% + 300 mg paracetamol diluted with saline to a total volume of 40 ml.

干预措施: Lidocaine (Drug)

结局指标

主要结局

The time to first analgesic request.

时间窗: 1 year

The time from tourniquet release until first patient request for analgesic

次要结局

  • sensory block(1 year)
  • motor block(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar Rabiee Ali

Resident doctor at the department of anaesthesiology and ICU

Assiut University

研究点 (1)

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